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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K123144

VIVO 50 · Ge Healthcare, Breas Medical AB · decided 2013-06-18 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Vivo 50007219Breas Medical ABNOU07321820072194
Vivo 50USBreas Medical ABNOU07321822151163